Principal Scientist - Synthetic Molecule Process Chemistry

21h21 hours ago

Genentech

South San Francisco, US · Full-time · $144,900 – $269,100

About this role

Genentech is seeking a top-tier Principal Scientist in Chemistry with a proven record of sustained laboratory achievement and innovation to join our Synthetic Molecule Process Chemistry group. The Scientist leads from the bench as part of project-based research and development staff. Responsibilities include developing enabling chemistry and processes for Active Pharmaceutical Ingredient manufacturing.

Develop enabling chemistry during early and/or late stage research to support development-readiness decisions. Create processes to manufacture API from early development through Phase III route selection. Deliver API supply for early phase clinical development using developed enabling chemistry.

Work with the South San Francisco clinical manufacturing team to produce early phase GMP clinical supplies. Interact closely with discovery chemists and sourcing partners throughout development. Perform route selection for late stage GMP API manufacturing, focusing on safe, efficient, robust, environmentally sound chemistry.

Synthesize regulatory starting materials and establish a robust supply chain. Develop processes for controlling bulk API quality per cGMP, ICH, and FDA regulations. Maintain a high level scientific profile internally and externally through scholarly achievements and pipeline contributions.

Requirements

PhD in highly relevant scientific discipline with 0-3 years industry experience
Outstanding record of innovation and success in multiple projects over graduate, post-doctoral and industrial career with sustained publication record
Strong working knowledge of latest developments in contemporary synthetic organic and/or process chemistry including chemo- and bio-catalysis, organometallic chemistry
Expertise in asymmetric transformations, heterocyclic chemistry, and/or peptide chemistry
Ability to interact, learn and eventually lead in a CMC/cross functional environment
Ability to take initiative, provide strategic input, problem solve, work in teams, develop people and communicate clearly, both orally and in writing
Demonstrated experience at the kilogram delivery scale (preferred)

Responsibilities

Develop enabling chemistry during early and/or late stage research in support of early development-readiness decisions
Develop processes to manufacture Active Pharmaceutical Ingredient (API) in early development through Phase III route selection
Deliver API supply in early phase clinical development
Participate in the production of early phase GMP clinical supplies
Perform route selection for late stage GMP API manufacturing with safe, efficient, robust, environmentally sound chemistry
Synthesize regulatory starting materials and establish a robust supply chain
Develop processes suitable for controlling the quality of bulk API as required by cGMP, ICH and FDA regulations
Write relevant CMC sections of INDs and participate in developing a strategy for quality